FDA.reportPublic FDA data

IOPI®

Primary DI
10810091040291
Brand
IOPI®
Company
Iopi Medical LLC
Model
Report Generator v 1.0
Catalog number
5-8101
Device description
IOPI® Report Generator software is an accessory approved for use with the IOPI® Model 3.1 (Pro) and/or the Model 3.2 (Trainer), which are medical devices that measure, evaluate, and increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. This software provides healthcare professionals with a report of device usage to allow them to document and analyze patient progress and usage. This software is intended for clinical use only.
Published
2025-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKETransducer, Miniature Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKETransducer, Miniature PressurePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810091040291PackageGS11In Commercial Distribution
10810091040581PackageGS11In Commercial Distribution
10810091040284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081009104029110810091040291
1081009104058110810091040581
1081009104028410810091040284

GMDN Terms#

Term, Definition table
TermDefinition
Dynamometer force gaugeAn electrically-powered component of a digital (electric) dynamometer intended to measure and display and/or communicate forces during assessment of neuromuscular function. It is a small unit with a built-in force sensor and is intended to be used with an appropriate dynamometer attachment(s); it is not a complete dynamometer. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
425-549-0139info@iopimedical.com

Regulatory Flags#

DUNS number
828391396
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810091040246IOPI®Model 3.28-32012025-03-21
10810091040031IOPI®Model 3.18-31012022-10-20
10810091040048IOPI®Model 3.28-32012022-10-20
10810091040055IOPI®Report Generator v 1.05-81012022-10-20
10810091040239IOPI®Model 3.18-31012025-03-21
10810091040284IOPI®Report Generator v 1.05-81012025-03-21
10810091040253IOPI®Model 3.18-31012025-03-21
10810091040277IOPI®Model 3.28-32012025-03-21
10810091040000IOPI®Model 3.18-31012022-10-20
10810091040024IOPI®Model 3.28-32012022-10-20
10810091040062IOPI®Report Generator v 1.05-81012022-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810091040239IOPI®Iopi Medical LLCIKE2025-03-21
10810091040246IOPI®Iopi Medical LLCIKE2025-03-21
10810091040284IOPI®Iopi Medical LLCIKE2025-03-21
10810091040253IOPI®Iopi Medical LLCIKE2025-03-21
10810091040277IOPI®Iopi Medical LLCIKE2025-03-21
00816271020797myoRESEARCHNoraxon U.S.A., Inc.IKE2023-06-07
10810091040031IOPI®Iopi Medical LLCIKE2022-10-20
10810091040048IOPI®Iopi Medical LLCIKE2022-10-20
10810091040055IOPI®Iopi Medical LLCIKE2022-10-20
10810091040000IOPI®Iopi Medical LLCIKE2022-10-20
10810091040024IOPI®Iopi Medical LLCIKE2022-10-20
10810091040062IOPI®Iopi Medical LLCIKE2022-10-20